Diagnosis: Digestive System/Gastrointestinal.
Treatment: Pharmacy/Prescription Drugs.

The insurer denied Stelara 90 milligrams (mg) every 4 weeks.
The denial is overturned.

The patient is a female with a history of Crohn's disease (CD). She previously tried and failed mesalamine and corticosteroids. She was then started on Stelara standard dose (90 milligrams [mg] every 8 weeks). However, she continued to have active disease and was escalated to 90 mg every 4 weeks. She responded well to the higher dose.
The requested service is the medical necessity of Stelara at 90 mg every 4 weeks.

The health plan's determination is overturned.

Stelara is approved by the Food and Drug Administration for treating Crohn's disease in adults. The approved dose is 90 mg every 8 weeks. However, dose escalation is often required in order to achieve therapeutic levels. There are many peer-reviewed literature reports showing that low Stelara levels were associated with poor clinical response. The requested dose of 90 mg every 4 weeks is proven to be effective in patients who fail the standard dose.
Per Ollech, Jacob E., et al: "Shortening the ustekinumab 90 mg dose interval to 4 weeks for patients with CD who did not respond to doses every 8 weeks improved clinical and biological indices of disease activity. Patients who lose response to the standard dose of ustekinumab might benefit from dose interval shortening, which was effective and safe."
Per Cohen, Erica et al: "A majority of patients with moderate to severe CD benefited from ustekinumab (UST) dose escalation suggesting the clinical utility of optimizing dosing in the treatment course. "
This patient has a history of refractory Crohn's disease which failed conventional therapy and Stelara at the standard dose (90 mg every 8 weeks). She responded well to the requested dose. Therefore, continuation of Stelara at the requested dosing regimen is medically necessary.